GPC Medical Hiring Regulatory Affairs Executive
About Company
GPC Medical Ltd. is an Indian hospital and medical supplies company with decades of experience in supplying high-quality medical equipment and orthopedic implants/instruments globally. The company is ISO 13485 Certified, WHO-GMP Compliant, and many of its products are CE Marked. GPC Medical specializes in Orthopedic Implants, Medical Disposables, Hospital Furniture, and Autoclave Sterilizers, with products supplied to almost all European countries.
Position Name: Regulatory Affairs Executive
Organization: GPC Medical Ltd.
Qualification: B.Pharm, M.Pharm, MSc, BSc, B.Tech, M.Tech
Experience: 1 to 2 Years
Salary: ₹25,000 – ₹35,000 /month
Location: Delhi Cantonment, Delhi, India (On-site)
Responsibilities
| Task | Details |
|---|---|
| Technical Documentation | Prepare and update technical documentation as per EU MDR and 510(k) regulatory requirements. |
| Risk Management | Prepare and update risk management and usability evaluations compliant with ISO 14971. |
| Labeling and Promotional Materials | Prepare or review labeling, IFU, surgical techniques, and promotional materials. |
| SOPs Management | Prepare and update divisional SOPs, recommending timely changes for compliance. |
| Regulatory Documents Compilation | Compile regulatory documents (TMF/Dossiers) for submission. |
| Design Files Creation | Create design files adhering to ISO 13485:2016, MDR, and USFDA standards. |
| Adverse Event Reporting | Manage adverse event reporting to EU and other regulatory agencies. |
| Clinical Evaluation Files | Prepare and revise PMS, PMCF, PSUR, and clinical evaluation files per Regulation (EU) 2017/745. |
| Regulatory Compliance | Apply knowledge of regulatory frameworks, processes, and procedures to maintain compliance. |
| Regulatory Task Tracking Systems | Monitor and improve regulatory task tracking systems and manage the team efficiently. |
| Stakeholder Interaction | Interact effectively with internal and external stakeholders (Notified Bodies, distributors, suppliers, and other regulatory authorities). |
